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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

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One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

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Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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A Florida-based stem cell clinic and a network of about 100 clinics in California are facing litigation brought on by the US Food and Drug Administration (FDA) to cease the marketing of their products.

The agency filed two complaints in federal court for permanent injunctions against US Stem Cell Clinic—which failed to address GMP violations revealed in an August 2017 warning letter—and the California Stem Cell Treatment Center and Cell Surgical Network Corporation, as they have yet to obtain FDA approval for the stem cell and biological products they have been administering to US patients for years.

GMP violations at US Stem Cell Clinic that FDA investigators found during inspections in April and May 2017 are associated with at least 256 lots of stem cell products, according to the agency.

“For example, the clinic was cited for its failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections,” FDA said.

In August 2017, FDA also moved to seize five vials of a smallpox vaccine from StemImmune that was not available on the US market, but was being administered to patients at the California Stem Cell Treatment Center facilities in Rancho Mirage and Beverly Hills.

GMP violations had been cited at these facilities as well, including FDA’s example for US Stem Cell Clinic.

It was confirmed during site inspections that the vaccine was being used to create a stem cell product—also derived from body fat and unapproved by FDA—that had been administered intravenously to cancer patients. The experimental treatment was also used on patients with arthritis, stroke, multiple sclerosis, macular degeneration and diabetes, among other conditions.

FDA Commissioner Scott Gottlieb said that while the agency supports “sound, scientific research and regulation of cell-based regenerative medicine” it will “continue to take enforcement actions against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by purporting to have treatments that are being manufactured and used in ways that make them drugs under the existing law but have not been proven safe or effective for any use.”

Per FDA's request, the US Department of Justice filed the complaints against US Stem Cell Clinic and the California Cell Treatment Center in the federal courts for the Southern District of Florida and the Central District of California, respectively.

In response, US Stem Cell Clinic posted a news release on its website stating that it "believes that the patient and physician have the right to decide whether or not to use a patient’s own cells for a therapeutic purpose without federal government interference."

The enforcement actions—announced late Wednesday—are part of a new FDA framework for regenerative medicine, including adult stem cells, on development and oversight that was set forth in a collection of four guidance documents last November in response to provisions in the 21st Century Cures Act of 2016.

Too little, too late?

Considering that the businesses had been operating in violation of federal law for several years, why FDA acted later rather than sooner and why these are the only ones being targeted remains unclear.

The risks to patient health at these stem cell businesses date back to at least 2012—which is when Leigh Turner, associate professor at the University of Minnesota Center for Bioethics, School of Public Health, & College of Pharmacy—began bringing the issues to FDA’s attention.

As identified in letters Turner sent to FDA—urging the agency to take action against US Stem Cell Clinic and the California Stem Cell Treatment Center, among others—over the course of a few years without a response, the businesses were “making all kinds of unsubstantiated claims about stem cell treatments” and marketing these treatments for “dozens of diseases and injuries,” he told Focus.

“A lot of the other companies that I wrote to the FDA about stayed in the marketplace and got bigger and bigger and attracted more patients,” Turner added. He estimates the number of stem cell clinics operating in the US under conditions that violate federal law has reached a total of more than 700.

From the birth of many of these businesses around 2009 or 2010, they “began to expand at a fairly rapid pace,” Turner said, posing the question of why so many years with these “wild, unsubstantiated claims about stem cell treatments” proliferating across the US before FDA intervened.

Turner argues the agency has come increasingly under pressure to protect patients from harm and financial losses over a lack of evidence to back the companies’ advertised products by going to court in its attempt to cease their operations, following media reports and several different case studies.

The growing public awareness around the businesses’ violations also involve an increasing number of lawsuits filed by patients exposing their practices of marketing interventions unsupported by clinical evidence, Turner added. Being forced to take legal action is “the kind of thing that could happen when you allow companies like these to operate and you don’t shut them down in a timely fashion,” he said.